MAUDE Adverse Event Report: HU-FRIEDY MFG. CO. LLC SWIVEL DIRECT FLOW ULTRASONIC INSERT; SCALER, ULTRASONIC

Model Number	UI25SD1000
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Hu-friedy has requested additional information from the user facility regarding the patient status; however, to date a response has not been received.The device subject of the event was returned for evaluation and it was confirmed that the tip of the insert was broken.The damage may have been caused by facility personnel dropping or mishandling the insert.A follow-up mdr will be submitted should additional information become available.
Event or Problem Description
The user facility reported that the tip of their swivel direct flow ultrasonic insert detached in the patient's mouth during a dental procedure.It was reported that the patient was sent to receive x-rays.The head x-ray confirmed that no piece of the insert was present.

• Brand Name: SWIVEL DIRECT FLOW ULTRASONIC INSERT
• Common Device Name: SCALER, ULTRASONIC
• Manufacturer (Section D): HU-FRIEDY MFG. CO. LLC; 3232 n rockwell st.; chicago IL 60618
• Manufacturer (Section G): HU-FRIEDY MFG. CO. LLC; 3232 n rockwell st.; chicago IL 60618
• Manufacturer Contact: daniel davy ; 5960 heisley rd; mentor, OH 44060 ; 4403927453
• MDR Report Key: 14225914
• Report Number: 1416605-2022-00001
• Device Sequence Number: 5563226
• Product Code: ELC
• UDI-Device Identifier: 10889950075385
• UDI-Public: 10889950075385
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: UI25SD1000
• Device Catalogue Number: UI25SD1000
• Device Lot Number: 1121
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/28/2022
• Initial Report FDA Received Date: 04/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown